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Phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy of pre-surgical HPV9-valente vaccination in women treated with loop electrosurgical excision (LEEP) for high-grade cervical intraepithelial neoplasia (CIN2+) up to cervical cancer initially invasive (FIGO IA1) - HOPE 9 STUDY

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513704-34-00
Acronym
HOPE 9 STUDY
Enrollment
1220
Registered
2024-06-24
Start date
2021-10-01
Completion date
2025-12-15
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical cancer

Brief summary

evaluation of the reduction of disease recurrence (cervical intraepithelial neoplasia up to microinvasive cervical cancer) by comparing the number of recurrences in the two arms.

Detailed description

Analysis of the impact of the vaccine on prevalent post-surgery infections by comparing the prevalence of persistent HPV infections (duration greater than 12 months after surgery) in the two arms., Analysis of the impact of the vaccine in the post-surgical surveillance times, comparison of the viral wash-out times (negativity of the HPV test), times of negativization of the pap test and of the colposcopic exam in the post-operative period: comparison of the overexposed times of negativization in the two arms.

Interventions

Sponsors

Azienda Unita Sanitaria Locale Toscana Nord Ovest
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
evaluation of the reduction of disease recurrence (cervical intraepithelial neoplasia up to microinvasive cervical cancer) by comparing the number of recurrences in the two arms.

Secondary

MeasureTime frame
Analysis of the impact of the vaccine on prevalent post-surgery infections by comparing the prevalence of persistent HPV infections (duration greater than 12 months after surgery) in the two arms., Analysis of the impact of the vaccine in the post-surgical surveillance times, comparison of the viral wash-out times (negativity of the HPV test), times of negativization of the pap test and of the colposcopic exam in the post-operative period: comparison of the overexposed times of negativization in the two arms.

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026